| Trial ID: | L1968 |
| Source ID: | NCT05409027
|
| Associated Drug: |
Spi-62
|
| Title: |
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus in Obese|Obesity|Type2Diabetes
|
| Interventions: |
DRUG: SPI-62|DRUG: Cortisone-d8
|
| Outcome Measures: |
Primary: Pharmacokinetics (Cmax), Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax), Days 1 through 14 | Secondary: Pharmacokinetics (tmax), Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Time to Cmax (tmax), Days 1 through 14|Pharmacokinetics (AUC0-t), Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Area Under the Curve over the dosing interval, Days 1 through 14|Cortisone-d8 concentrations, individual values, Days 1 through 14|Urinary HSD-1 Ratio, Individual values of the urinary HSD-1 ratio defined as (tetrahydrocortisol + allotetrahydrocortisol) / tetrahydrocortisone, Days -1 to 15
|
| Sponsor/Collaborators: |
Sponsor: Sparrow Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2021-07-23
|
| Completion Date: |
2024-02-07
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-22
|
| Locations: |
ProSciento, Chula Vista, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05409027
|
